Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE

Atrial Fibrillation Clinical Trial

— EAST-STROKE  

Official title:

Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05293080
• Other study ID #: EAST-STROKE
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2024
• Est. completion date: March 2029

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Märit Jensen, MD
• Phone: +4940741053770
• Email: m.jensen[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.

Description:

trial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. Usual care comprises oral anticoagulation and rate control. However, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (PROBE) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. Secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. In an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1746
• Est. completion date: March 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) or clinical diagnosis
• Possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable
• AF first detected =1 year prior to randomization
• Informed consent

Exclusion Criteria:

• End-stage cancer or life-expectancy < 12 months due to other advanced co-morbid illness
• Prior AF ablation or surgical therapy of AF
• Patients not suitable for rhythm control of AF due to cardiac conditions

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Atrial Fibrillation
• Ischemic Stroke
• Stroke

Intervention

Other:
• Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)
Therapy for early rhythm control will be either by use of approved antiarrhythmic drugs (e.g. amiodarone, dronedarone, flecainide, propafenone), approved approaches and devices for ablation, or electric cardio version.
• Usual care for atrial fibrillation
Usual care for atrial fibrillation according to current guidelines. Usual care will mainly comprise rate control by approved drugs. We expect, that usual care will also comprise therapy for rhythm control in a small group of patients.

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor

Collaborator

Universitätsklinikum Hamburg-Eppendorf

CTC-NORTH, Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre, Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Department of Neurology, Royal Melbourne Hospital, Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh, Hotchkiss Brain Institute, University of Calgary, Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Kompetenznetz Vorhofflimmern e.V. (AFNET), Melbourne Heart Centre, Royal Melbourne Hospital, Stroke Alliance for Europe (SAFE), UMC Utrecht, University Heart & Vascular Center Hamburg, Department of Cardiology

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause mortality	Death from any cause	Through study completion, an average of 42 months
Other	Severe bleeding complications	Intracranial hemorrhage, major bleeding	Through study completion, an average of 42 months
Other	Adverse events	Adverse events related to the study intervention with special emphasis on proarrhythmia and complications due to interventions	Through study completion, an average of 42 months
Primary	Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.	The primary outcome measure is a composite of first recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or due to acute coronary syndrome as recorded by study investigators	Through study completion, an average of 42 months
Secondary	Time to first recurrent stroke	Recurrent stroke as recorded by study investigators	Through study completion, an average of 42 months
Secondary	Time to cardiovascular death		Through study completion, an average of 42 months
Secondary	Time to first hospitalization due to worsening of heart failure	Hospitalization due to worsening of heart failure as recorded by study investigators	Through study completion, an average of 42 months
Secondary	Time to hospitalization due to acute coronary syndrome	Hospitalization due to acute coronary syndrome as recorded by study investigators	Through study completion, an average of 42 months
Secondary	Time to recurrent AF		Through study completion, an average of 42 months
Secondary	Cardiovascular hospitalization	Cardiovascular hospitalization as recorded by study investigators	Through study completion, an average of 42 months
Secondary	All-cause hospitalizations	All-cause hospitalizations as recorded by study investigators	Through study completion, an average of 42 months
Secondary	Time in sinus rhythm		Through study completion, an average of 42 months
Secondary	Functional status assessed by the modified Rankin Scale	Modified Ranking Scale ranging from 0 (no symptoms) to 6 (death) with lower values indicating better status	at 12 and 24 months
Secondary	Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D)	The EQ-5D index will be calculated with higher values indicating better health state	at 12 and 24 months
Secondary	Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)	The MoCA ranges for 0 to 30, with higher values indicating better cognitive function	at 12 and 24 months
Secondary	Cost of therapy		Through study completion, an average of 42 months